In September 2021, the US Food and Drug Administration (FDA) published the first update to its Bioresearch Monitoring (BIMO) Compliance Program Manual for Sponsors and Contract Research Organizations since 2017. This document, which serves as FDA’s standard operating procedure for conducting a GCP inspection, is a critical resource for sponsors and CROs preparing for inspections. Other than a change in fonts, what's new? The manual has been restructured to be more intuitive.  For example, Outsourced Services is its own section; Data Collection and Handling now directly proceeds Electronic Records and Electronic Signatures; the section formerly known as "Test Article" has been renamed "Investigational Product." The manual also adds a significant amount of detail to the sections on safety reporting and data handling. Sponsors typically prepare to discuss these newly-enumerated issues during an inspection, but there are a few surprises. Overall, the impression is that FDA inspectors are putting the spotlight on process, more in line with their EMA counterparts. Here are some highlights:

• More detail on inspection of site selection procedures, including review of investigator qualifications and debarment procedures
• New section on outsourced services with focus on detailed written agreements; inspectors are required to verify that agreements specify responsibilities for complying with FDA regulations as well as approval responsibilities for study activities
• Added emphasis on sponsor oversight, including escalation plans and audits
• New steps for evaluating whether monitoring included source verification of data changes and how monitors ensured confidentiality and security of records during remote monitoring
• New DSMB/DMC section
• Greatly expanded safety section, including steps for reviewing aggregate reporting procedures, surveillance activities, risk management, and criteria for selection of medical monitors
• More detailed data handling section with focus on validation, user access control, and change control of study-specific systems as well as data integrity during transfers and transformations

We'll be looking at these new and expanded sections in detail in future blog posts. Meanwhile, download the updated manual here. Photo by David Pisnoy on Unsplash